FDA Registration
Active
🇺🇸 United States
SURGIX MEDICAL LLC
Reg #: 3012995405
·
FEI: 3012995405
·
Expires 2026
Products
102
Proprietary Names
109
Establishment Types
2
Classifications
102
Registration Details
- Registration Name
- SURGIX MEDICAL LLC
- Registration Number
- 3012995405
- FEI Number
- 3012995405
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 22317 GOSLING RD
- City
- Spring
- State
- TX
- ZIP
- 77389
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120492
Owner / Operator
- Firm Name
- Surgix Medical, L.L.C.
- Operator Number
- 10052923
- Address
- 22317 Gosling Rd
- City
- Spring
- State
- TX
- Postal Code
- 77389
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-06-09 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2022-03-21 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2022-03-17 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2024-01-03 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2022-03-21 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2022-03-21 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2022-03-17 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2022-03-21 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2022-03-17 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2022-03-21 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2023-01-05 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2025-06-12 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2022-03-17 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2025-02-06 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Skid, Bone | HWO | Class 1 | Orthopedic | No | 2022-03-21 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2022-09-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2024-09-16 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2022-03-17 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2022-03-21 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Cannula, Ventricular | HCD | Class 1 | Neurology | No | 2026-04-09 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2022-03-21 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2022-03-21 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-03-21 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2022-04-18 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2023-08-31 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2025-06-12 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2024-01-03 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2024-01-03 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2023-01-05 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2022-04-18 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-04-26 |
| Crimper, Wire, Ent, Non-Sterile | NNN | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2022-04-18 |
| Bender | HXW | Class 1 | Orthopedic | No | 2022-03-21 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2022-03-17 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Table, Surgical With Orthopedic Accessories, Ac-Powered | JEA | Class 1 | General, Plastic Surgery | No | 2022-02-15 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2022-03-21 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-03-17 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2023-01-05 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-01-08 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2022-03-21 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2023-08-31 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2023-01-05 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2022-03-21 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-03-21 |
| Dilator, Vessel, Surgical | DWP | Class 2 | Cardiovascular | No | 2022-04-18 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2022-03-21 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2022-03-17 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2023-01-05 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2023-06-05 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2023-01-05 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2022-03-21 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2024-09-16 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2022-03-21 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2022-03-17 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2025-01-08 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2022-03-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-06-05 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2025-01-08 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-03-21 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2024-01-03 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Probe | HXB | Class 1 | Orthopedic | No | 2022-03-21 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2024-04-01 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-12-17 |
| Handpiece (Brace), Drill | HBD | Class 1 | Neurology | No | 2022-03-21 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2022-03-21 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2022-04-18 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 2022-03-21 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2022-03-21 |
Proprietary Names
Disposable Bedding
Wire Cutter
Hemostatic Forceps
GEN2 Rasp
Surgical Instrument Non-powered
Ophthalmic Caliper
Surgical Guide Instrument
Spatula
Ear Scissors
Dissector
Microsurgical Instrument
Forceps
Lachrymal Dilator
GEN2 VAGINAL RETRACTOR
Loop, Wire
Currette
Tonsil Needle
Ligature Passing and Knot Tying Instrument
Amputation Knife
Nasal Chisel
Surgical Knife
Gouge
Bone Skid
Nasal Scissors
Gen2 Clampbox
Gen2 Single Clamp
Gen2 Clamp
Kay Aortic Clamp
Gen2 Approximator Clamp
Bowman Probe
Instrument Stringer W/Bar 6" X 2.5"
Ear Measuring Rod
GEN2 Trabeculotomy Probe
Scissors, Surgical
Self-Retaining Retractor
ENT Punch
GEN2 Ventricular Cannula
Forceps, ENT
Orbital Depressor
Nipper, Malleus
Bone Impactor
Tongue Depressor
Reamer
Retractor
Segmented Oval Ring
GEN2 Female Catheter
Lachrymal Probe
GEN 2 Orthopedic Instrument
GEN2 Tuning Fork
GEN2 Uterine Curette
Ear Knife
Rongeur
GRAVES VAGINAL SPECULUM MEDIUM BW35mm BL 106MM OL 5 1/8"
Cohen Acorn Cannula Intrauterine Probe Spring-mount Forcep,Small and Large Cones,Diameter 3.5mmOL369mm(14 1/2")
Cohen Acorn Small Cone, Tube 3.24mm, TL 31mm OL 60mm(2 3/8")
Non-sterile ENT Wire Crimper
Multihole Suction Tube
Bender
Chisel
Nasal Knife
Needle Holder
Rasp
Surgical Instrument Tray
Middle-ear Chisel
Ophthalmic Cannula
GEN2 UTERINE SOUND
Bone Chisel
ENT Manual Surgical Instrument
Blade, Saw, General & Plastic Surgery
GEN2 Uterine Grasping Forcep
Scapel Handle
Specula
GEN2 SPECULA
ENT Knife
Probe and Director
Suction Tube
Manual Surgical Instrument
GARRETT VASCULAR DILATOR
VASCULAR DILATOR
Iris Scissors
Ligature Carrier
GEN2 GYN FORCEPS
Surgical Table Disposable Cover Kit
GEN2 BIO FORCEP
Dilator
GEN 2 Ophthalmic Forceps
Ophthalmic Retractor
Clamp
Surgical Mallet
Opthalmic Hook
Orthopedic Rongeur
GEN2 Drill Bit
Caliper
Ruler
Depth Gauge
Ear Excavator
GEN2
Elevator
Ear Pick
Probe
GEN 2 Scoop
Eco-Friendly Forceps
Stingray bipolar forceps
Handpiece (Brace), Drill
Pliers, Ortho
Hook, Surgical
SUCTION CANNULA
Antrum Punch
Osteotome
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility